risk

As I have mentioned before, I like positive news as much as the next person. Therefore, I am constantly on the look-out for recently published, sound evidence suggesting that some form of alternative medicine is effective and safe for this or that condition. This new systematic review fits that description, I am pleased to report.

Its authors evaluated the effectiveness of massage therapy (MT) for neck and shoulder pain. Their extensive literature searches identified 12 high-quality studies. The meta-analyses showed significant effects of MT for neck pain and shoulder pain compared to inactive therapies. MT did not yield better effects for neck pain or shoulder pain than other active therapies administered to the control groups. Shoulder function was not significantly affected by MT. The authors concluded that “MT may provide immediate effects for neck and shoulder pain. However, MT does not show better effects on pain than other active therapies. No evidence suggests that MT is effective in functional status”.

Massage therapy is thus a promising treatment, particularly as this systematic review is by no means the only piece of encouraging evidence. It is not better than other effective treatments, but it is not associated with frequent or serious adverse effects. This means that the demonstrable benefits are likely to outweigh its risks; in other words, the risk benefit balance is positive. Regular readers of this blog will appreciate the importance of this point.

Massage is practiced by several professions: mostly, of course, by massage therapists, but occasionally also by nurses, osteopath, chiropractors etc. Chiropractors, in particular, have recently tried to make much – I think too much – of this fact. They tend to claim that, as they use treatments which are evidence-based, such as massage, chiropractic is an evidence-based profession. I think this is akin to surgeons claiming that all of surgery is evidence-based because surgeons use medications which effectively reduce post-operative pain. Chiropractors foremost employ spinal manipulation and surgeons foremost use surgery; if they want us to believe that their practice is evidence-based, they need to show us the evidence for their hall-mark interventions. In the case of surgery, the evidence is mostly established; in the case of chiropractic, it is mostly not.

Massage is backed by reasonably sound evidence not just for neck and shoulder pain but for a range of otherconditions as well. WHAT DO WE CALL AN ALTERNATIVE MEDICINE THAT WORKS? WE CALL IT MEDICINE!

So why is massage not a mainstream therapy? The answer is simple: in many countries, massage therapy has long been considered to be entirely conventional. Twenty years ago, I was chair of rehabilitation medicine at the university of Vienna. Amongst my staff, there always were about 5-8 full time massage therapists and nobody thought this to be unusual in any way. Similarly, in Germany, massage is entirely conventional.

Perhaps it is time that the English-speaking countries catch up with Europe when it comes to massage therapy and the evidence that supports it?

Believe it or not, but my decision – all those years ago – to study medicine was to a significant degree influenced by a somewhat naive desire to, one day, be able to save lives. In my experience, most medical students are motivated by this wish – “to save lives” in this context stands not just for the dramatic act of administering a life-saving treatment to a moribund patient but it is meant as a synonym for helping patients in a much more general sense.

I am not sure whether, as a young clinician, I ever did manage to save many lives. Later, I had a career-change and became a researcher. The general view about researchers seems to be that they are detached from real life, sit in ivory towers and write clever papers which hardly anyone understands and few people will ever read. Researchers therefore cannot save lives, can they?

As I am retiring from academic life and doing less original research, I do have the time and the inclination to brood over such questions. What precisely motivated my research agenda in alternative medicine, and why did I remain unimpressed by the number of powerful enemies I made pursuing it?

If I am honest – and I know this will sound strange to many, particularly to those who are convinced that I merely rejoice in being alarmist – I am still inspired by this hope to save lives. Sure, the youthful naivety of the early days has all but disappeared, yet the core motivation has remained unchanged.

But how can research into alternative medicine ever save a single life?

Since about 20 years, I am regularly pointing out that the most important research questions in my field relate to the risks of alternative medicine. I have continually published articles about these issues in the medical literature and, more recently, I have also made a conscious effort to step out of the ivory towers of academia and started writing for a much wider lay-audience (hence also this blog). Important landmarks on this journey include:

Alternative medicine is cleverly, heavily and incessantly promoted as being natural and hence harmless. Several of my previous posts and the ensuing discussions on this blog strongly suggest that some chiropractors deny that their neck manipulations can cause a stroke. Similarly, some homeopaths are convinced that they can do no harm; some acupuncturists insist that their needles are entirely safe; some herbalists think that their medicines are risk-free, etc. All of them tend to agree that the risks are non-existent or so small that they are dwarfed by those of conventional medicine, thus ignoring that the potential risks of any treatment must be seen in relation to their proven benefit.

For 20 years, I have tried my best to dispel these dangerous myths and fallacies. In doing so, I had to fight many tough battles (sometimes even with the people who should have protected me, e.g. my peers at Exeter university), and I have the scars to prove it. If, however, I did save just one life by conducting my research into the risks of alternative medicine and by writing about it, the effort was well worth it.

Fairly early on during my time at Exeter, I had felt that it would be relevant, interesting and important to familiarise general practitioners with alternative medicine. At the time, we decided that we would start to run regular courses specifically for these health care professionals. Back in the mid 1990s, this was a remarkable thing to do, so much so that we even published our experience after the first such event. Recently I came across the article that resulted from this endeavour; here is an except from the abstract:

The delegates started with a positive but questioning attitude toward complementary medicine (CM) and acknowledged that they gained useful information, leading to increased confidence in discussing CM with patients. The course to a large extent met their needs and expectations. Benefits and draw-backs of integrating CM within general practice were explored. The main advantage of CM, apart from the potential intrinsic value of the techniques themselves, was identified as the time to establish a good therapeutic relationship with the patient. The particular concerns about CM that were expressed by the doctors included poor dialogue with CM practitioners, doubts about competence, and lack of readily identifiable and recognized qualifications. The risk of holding out unrealistic hope of cure was their greatest concern, however, especially if patients were thereby denied an effective orthodox treatment.

What strikes me as particularly remarkable is the fact that, even then, so many doubts were voiced by our GPs about alternative practitioners, their therapeutic claims and their doubtful medical competence. It was then that it occured to me for the first time that these therapists might systematically misinform their patients. This suspicion was strengthened on numerous occasions in the years to come; but it was not until much later that we decided to look into this subject (which is rather difficult to research) more systematically. What we found shocked us. Here are the conclusions of some of our investigations:

The most popular websites on complementary and alternative medicine for cancer offer information of extremely variable quality. Many endorse unproven therapies and some are outright dangerous. The link to the article is here.

Some complementary and alternative medicine (CAM) providers have a negative attitude towards immunisation and means of changing this should be considered. The link is here.

Advice about herbal medicine is readily available over the Internet. The advice offered is misleading at best and dangerous at worst. Potential Internet users should be made aware of these problems and ways of minimizing the risk should be found. The link is here.

The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue. The link is here.

In another study, we found that advice given by alternative practitioners to diabetic patients had the potential to kill them. A similarly scary conclusion emerged when we evaluated the advice chiropractors provide to asthma patients. Other research found that anthroposophic doctors often advise against measles vaccinations and are thus causing measles outbreaks.

The totality of this evidence, I believe, begs the question: DO ALTERNATIVE PRACTITIONERS SYSTEMATICALLY MISINFORM THEIR PATIENTS? I look forward to a lively discussion of it.

Still in the spirit of ACUPUNCTURE AWARENESS WEEK, I have another critical look at a recent paper. If you trust some of the conclusions of this new article, you might think that acupuncture is an evidence-based treatment for coronary heart disease. I think this would be a recipe for disaster.

This condition affects millions and eventually kills a frighteningly large percentage of the population. Essentially, it is caused by the fact that, as we get older, the blood vessels supplying the heart also change, become narrower and get partially or even totally blocked. This causes lack of oxygen in the heart which causes pain known as angina pectoris. Angina is a most important warning sign indicating that a full blown heart attack might be not far.

The treatment of coronary heart disease consists in trying to let more blood flow through the narrowed coronaries, either by drugs or by surgery. At the same time, one attempts to reduce the oxygen demand of the heart, if possible. Normalisation of risk factors like hypertension and hypercholesterolaemia are key preventative strategies. It is not immediate clear to me how acupuncture might help in all this – but I have been wrong before!

The new meta-analysis included 16 individual randomised clinical trials. All had a high or moderate risk of bias. Acupuncture combined with conventional drugs (AC+CD) turned out to be superior to conventional drugs alone in reducing the incidence of acute myocardial infarction (AMI). AC+CD was superior to conventional drugs in reducing angina symptoms as well as in improving electrocardiography (ECG). Acupuncture by itself was also superior to conventional drugs for angina symptoms and ECG improvement. AC+CD was superior to conventional drugs in shortening the time to onset of angina relief. However, the time to onset was significantly longer for acupuncture treatment than for conventional treatment alone.

From these results, the authors [who are from the Chengdu University of Traditional Chinese Medicine in Sichuan, China] conclude that “AC+CD reduced the occurrence of AMI, and both acupuncture and AC+CD relieved angina symptoms and improved ECG. However, compared with conventional treatment, acupuncture showed a longer delay before its onset of action. This indicates that acupuncture is not suitable for emergency treatment of heart attack. Owing to the poor quality of the current evidence, the findings of this systematic review need to be verified by more RCTs to enhance statistical power.”

As in the meta-analysis discussed in my previous post, the studies are mostly Chinese, flawed, and not obtainable for an independent assessment. As in the previous article, I fail to see a plausible mechanism by which acupuncture might bring about the effects. This is not just a trivial or coincidental observation – I could cite dozens of systematic reviews for which the same criticism applies.

What is different, however, from the last post on gout is simple and important: if you treat gout with a therapy that is ineffective, you have more pain and eventually might opt for an effective one. If you treat coronary heart disease with a therapy that does not work, you might not have time to change, you might be dead.

Therefore I strongly disagree with the authors of this meta-analysis; “the findings of this systematic review need NOT to be verified by more RCTs to enhance statistical power” — foremost, I think, the findings need to be interpreted with much more caution and re-written. In fact, the findings show quite clearly that there is no good evidence to use acupuncture for coronary heart disease. To pretend otherwise is, in my view, not responsible.

There might be an important lesson here: A SEEMINGLY SLIGHT CORRECTION OF CONCLUSIONS OF SUCH SYSTEMATIC REVIEWS MIGHT SAVE LIVES.

In 2010, I have reviewed the deaths which have been reported after chiropractic treatments. My article suggested that 26 fatalities had been published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery. Whenever I write about the risks of spinal manipulation, chiropractors say that I am irresponsible and alarmist. Yet I believe I am merely doing my duty in alerting health care professionals and the public to the possibility that this intervention is associated with harm and that caution is therefore recommended.

Fortunately, I am not alone, as a new report from China shows.This review summarised published cases of injuries associated with cervical manipulation in China, and to describe the risks and benefits of the therapy.

The authors conclude that “it is imperative for practitioners to complete the patients’ management and assessment before manipulation. That the practitioners conduct a detailed physical examination and make a correct diagnosis would be a pivot method of avoiding accidents. Excluding contraindications and potential risks, standardizing evaluation criteria and practitioners’ qualification, increasing safety awareness and risk assessment and strengthening the monitoring of the accidents could decrease the incidence of accidents” (I do apologize for the authors’ poor English).

It is probable that someone will now calculate that the risk of harm is minute. Chinese traditional healers seem to use spinal manipulation fairly regularly, so the incidence of complications would be one in several millions.

Such calculations are frequently made by chiropractors in an attempt to define the incidence rates of risks associated with chiropractic in the West. They look convincing but, in fact, they are complete nonsense.

The reason is that under-reporting can be huge. Clinical trials of chiropractic often omit any mention of adverse effects (thus violating publication ethics) and, in our case-series, under-reporting was precisely 100% (none of the cases we discovered had been recorded anywhere). This means that these estimates are entirely worthless.

I sincerely hope that the risk turns out to be extremely low – but without a functioning reporting system for such events, we might as well read tea-leaves.

I don’t suppose that many readers of this blog believe all things natural to be entirely safe, but the general public seems to be hard-wired victims of this myth: Mother Nature is benign, and herbal remedies must be harmless!

There are, of course, several reasons why supposedly “natural” herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated.

The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects.

Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen.

We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc.

To avoid such disasters, consumers need to know which types of herbal remedies are most frequently implicated; our review showed that these were foremost Chinese and Indian remedies. While herbal medicines from the US or Europe ought to comply with certain rules and regulations regarding their quality and safety, Chinese and Indian herbal mixtures frequently enter our countries illegally or are bought from dubious sources, for instance, over the Internet. It is this type of herbal remedy that we should be concerned about.

We have to ask whether the risks outweigh the proven benefits of Chinese or Indian herbal mixtures. The short answer to this question is NO. There is very little compelling evidence to suggest that these treatments are efficacious. In the absence of proven benefit, even small or rare risks weigh heavily.

If the risk-benefit profile for any medical intervention fails to be positive, there can only be one reasonable conclusion regarding the use of this therapy – and that is: DON’T DO IT!

I find most laudable that two osteopaths conduct research into medical ethics; but the questions still are, does the article tell us anything worth knowing and is it sufficiently rigorous and critical? As the journal does not seem to be available on Medline, I cannot provide a link. I therefore take the liberty of quoting the most important bits from directly the abstract here.

Objective: To explore and describe patients’ preferences of consent procedures in a sample of UK osteopathic patients.

Methods: A cross sectional survey using a new questionnaire was performed incorporating paper and web-based versions of the instruments. 500 copies were made available, (n = 200) to patients attending the British School of Osteopathy (BSO) clinic, and (n = 300) for patients attending 30 randomly sampled osteopaths in practice. Quantitative data were analysed descriptively to assess patient preferences; non-parametric analyses were performed to test for preference difference between patients using demographic characteristics.

Results: 124 completed questionnaires were returned from the BSO sample representing a 41% response rate. None were received from patients attending practices outside of the BSO clinic. The majority (98%) of patient respondents thought that having information about rare yet potentially severe risks of treatment was important. Patients’ preferred to have this information presented during the initial consultation (72%); communication method favoured was verbal (90%). 99% would like the opportunity to ask questions about risks, and all respondents (100%) consider being informed about their current diagnosis as important.

Conclusion: Patients endorse the importance of information exchange as part of the consent process. Verbal communication is very important and is the favoured method for both receiving information and giving consent. Further research is required to test the validity of these results in practice samples

The 0% response-rate in patients from non-BSO practices is, of course, remarkable and not without irony. In my view, it highlights better than anything else the fact that informed consent rarely appears on the osteopathic radar screen. In a way, this increases the praise we should give the two authors for tackling the issue.

The central question of the survey is whether patients want to know about the risks of osteopathy. This is more than a little bizarre: informed consent is not an option, it is a legal, moral and ethical obligation. It seems therefore odd to ask the question “do you want to learn about the risks which you are about to be exposed to?”

Even odder is, I think, the second question “when do you want to receive this information?” It goes without saying that informed consent has to happen before the intervention! This is what, common sense tells us, the law dictates and ethical codes prescribe.

There is general agreement amongst health care professionals and ethicist that verbal consent does suffice in most therapeutic situations, that patients must have the opportunity to ask questions, and that informed consent also extends to diagnostic issues. So, the questions referring to these issues are also a bit strange or naive, in my view.

The article might be revealing mostly by what it does not address rather than by what it tells us. It would be really valuable to know the percentage of osteopaths who abide by the legal, moral and ethical imperative of informed consent in their daily practice. To the best of my knowledge, this information is not available [if anyone has such information, please let me know and provide the reference]. Assuming that it is similar to the percentage of UK chiropractors who obtain informed consent, it might be seriously wanting: only 45% of them routinely obtain informed consent from their patients.

Another issue that, in my view, would be relevant to clarify is the nature of the information provided by osteopaths to patients, other than that of serious risks associated with spinal manipulation/mobilisation. Do they tell their patients about the evidence suggesting that osteopathy does (not) work for the condition at hand? Do they elaborate on non-osteopathic treatments for that disease? I fear that the answers to these questions might well be negative.

Imagine a patient being told that there is no good evidence for effectiveness of osteopathy, that the possibility of some harm exists, and that other interventions might actually do more good than harm than what the osteopath has to offer. How likely is it that this patient would agree to receiving osteopathic treatment?

For most alternative practitioners, including osteopaths, informed consent and most other important ethical issues have so far remained highly uncomfortable areas. This may have a good and simple reason: they have the potential to become real and serious threats to their current practice and business. I suspect this is why there is so very little awareness of and research into the ethics of alternative medicine: “best not to wake sleeping lions”, seems to be the general attitude.

The survey by Daniels and Vogel, even though it touches upon an important topic, avoids the truly pertinent questions. It therefore looks to me a bit like a fig leaf shamefully hiding an area of potential embarrassment.

And where do we go from here? I predict that the current strategy of alternative practitioners to ignore and violate medical ethics as much as possible will not be tolerated for much longer. Double standards in health care cannot and should not survive. The sooner we begin addressing some of these uncomfortable questions with rigorous research, the better – perhaps not for the practitioner but certainly for the patient.

“Don’t take this therapy lightly. Multiple sclerosis, colitis, lupus, rheumatoid arthritis, cancer, hepatitis, hyperactivity, pancreatic insufficiency, psoriasis, eczema, diabetes, herpes, mononucleosis, adrenal failure, allergies and so many other ailments have been relieved through use of this therapy. After you overcome your initial gag response (I know I had one), you will realize that something big is going on, and if you are searching for health, this is an area to investigate. There are numerous reports and double blind studies which go back to the turn of the century supporting the efficacy of using urine for health”. This quote refers to a treatment that I, and probably most readers of this blog, find truly amazing – even in the realm of alternative medicine, we do not often come across a therapy as bizarre as this one: urine therapy.

Urine therapy enthusiasts claim that your own urine administered either externally, internally or both, has a long history of use, that most medical cultures have usefully employed it, that many VIPs swear by it, that it can cure almost all diseases and that it can save lives. What was new to me is the claim that it is supported by numerous double-blind studies.

Such trials would, of course, be entirely feasible; all you need to do is to give one group of patients the experimental treatment, while the other takes a placebo. Recruitment might be a bit of a problem, and the ethics committee might raise one or two eyebrows but, in theory, it certainly seems doable. So where are the “numerous” studies?

A quick, rough and ready Medline-Search found several unfortunate authors with the last name of “URINE”, yet no clinical trials of urine therapy emerged. A little more time-consuming search through my books on alternative medicine revealed nothing that remotely resembled evidence. At this point, I arrived at the conclusion that the clinical trials are either non-existent or extremely well hidden. Further searches of the proponents’ literature, websites etc made me settle for the former explanation.

All this could be entirely irrelevant, perhaps slightly amusing, would it not reveal a pattern which is so painfully common in alternative medicine: anyone can claim anything without fear of any type of retribution, gullible consumers are attracted through the exotic flair, VIP-promotion, long history of use etc. and follow in droves [yes, amazingly, urine therapy seems to have plenty of followers]; consequently, lives are put at risk whenever someone starts truly believing the bogus, irresponsible claims that are being made.

I do apologise for the rudeness of my words but I really do think THEY ARE TAKING THE PISS!

Even though I have not yet posted a single article on this subject, it already proved to be a most controversial subject in the comments section. A new analysis of the evidence has just been published, and, in view of the news just out of a Royal Charter for the UK College of Chiropractors, it is time to dedicate some real attention to this important issue.

The analysis comes in the form of a systematic review authored by an international team of chiropractors (we should not fear therefore that the authors have an “anti-chiro bias”). Their declared aim was “to determine whether conclusive evidence of a strong association [between neck manipulation and vascular accidents] exists”. The authors make it clear that they only considered case-control studies and omitted all other articles.

They found 4 such publications all of which had methodological limitations. Two studies were of acceptable quality, and one of these studies seemed to show an association between neck manipulation and stroke, while the other one did not. The authors’ conclusion is ambivalent: “Conclusive evidence is lacking for a strong association between neck manipulation and stroke, but it is also lacking for no association”.

The 4 case-control studies, their strength and weaknesses are, of course, well-known and have been discussed several times before. It was also known that the totality of these data fail to provide a clear picture. I would therefore argue that, in such a situation, we need to include further evidence in an attempt to advance the discussion.

Generally speaking, whenever we assess therapeutic safety, we must not ignore case-reports. One might be next to meaningless but collectively they can provide strong indicators of risk. In drug research, for instance, they send invaluable signals about potential problems and many drugs have been withdrawn from the market purely on the basis of case-reports. If we include case-reports in an analysis of the risks of neck manipulations, the evidence generated by the existing case-control studies appears in a very different light. There are virtually hundreds of cases where neck manipulations have seriously injured patients, and many have suffered permanent neurological deficits or worse. Whenever causation is validated by experts who are not chiropractors and thus not burdened with a professional bias, investigators find that most of the criteria for a causal relationship are fulfilled.

While the omission of case-reports in the new review is regrettable, I find many of the staements of the authors helpful and commendable, particularly considering that they are chiropractors. They seem to be aware that, when there is genuine uncertainty, we ought to err on the safe side [the precautionary principle]. Crucially, they comment on the practical implications of our existing knowledge: “Considering this uncertainty, informed consent is warranted for cervical spinal manipulative therapy that advises patients of a possible increase in the risk of a rare form of stroke…” A little later, in their discussion they write: “As the possibility of an association between cervical spinal manipulative therapy and vascular accidents cannot be ruled out, practitioners of cervical spinal manipulative therapy are obliged to take all reasonable steps that aim to minimise the potential risk of stroke. There is evidence that cervical rotation places greater stresses on vertebral arteries than other movements such as lateral flexion, and so it would seem wise to avoid techniques that involve full rotation of the head.”

At this point it is, I think, important to note that UK chiropractors tend not to obtain informed consent from their patients. This is, of course, a grave breach of medical ethics. It becomes even graver, when we consider that the GCC seems to do nothing about it, even though it has been known for many years.

Is this profession really worthy of a Royal Charter? This and the other question raised here require some serious consideration and discussion which, no doubt, will follow this short post.